LWH
15 FDA 510(k) clearances · Product code
56 daysmedian time to decision
167 days90th percentile
15clearances measured
FDA profile
- Official device name
- Counter, Sponge, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2740
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 2021: 35 · 2022: 41 · 2023: 39 · 2024: 37 · 2025: 35 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PIXEL APP (K121274) | Gauss Surgical, Inc., | 2012-06-27 |
| PIXEL APP (K120473) | Gauss Surgical, Inc., | 2012-04-09 |
| ORLOCATE SYSTEM MODEL ORL 100 (K100551) | Haldor Advanced Technologies, Ltd. | 2010-08-12 |
| SMARTWAND-DTX (K093557) | Clearcount Medical Solutions | 2009-12-18 |
| SMARTSPONGE PLUS SYSTEM (K073180) | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| SMARTSPONGE SYSTEM (K071355) | Clearcount Medical Solutions, Inc. | 2007-05-24 |
| RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (K062642) | Rf Surgical Systems, Inc. | 2006-11-02 |
| MEDLINE SURGICAL SPONGE SCANNER (K061316) | Medline Industries, Inc. | 2006-11-02 |
| SURGICOUNT SAFETY-SPONGE SYSTEM (K060076) | Surgicount Medical | 2006-03-14 |
| MARKWELL GAUZE SPONGE (K982260) | Markwell Intl., Inc. | 1998-08-12 |
| POCKET COUNT OR SAFETCOUNT (K972302) | Sage Products, Inc. | 1997-07-25 |
| SPONGE COUNT (K945144) | Michael Fischer Assoc. | 1995-01-12 |
| DEVON SPONGE COUNTER BAGS (K912824) | Devon Industries, Inc. | 1991-08-26 |
| GORSK SPONGE CONTAINMENT SYSTEM (K873555) | Gorsk, Inc. | 1987-10-23 |
| SPONGE COUNTER (K790538) | Devon Industries, Inc. | 1979-04-04 |
Track LWH automatically
Every clearance here is in the API, with alerts when new ones post.